MAUDE Adverse Event Report: ARTHREX, INC. BIO-INTERFERENCE SCREW; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-INTERFERENCE SCREW
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/07/2024, it was reported by an arthrex subsidiary employee via email that an ar-1380b bio-interference screw with disposable sheath does not screw in the patient's tendon.The surgeon applied force to insert the screw, but it did not screw in.When the screw was removed, it appeared deformed.This was discovered during a knee arthroscopy and acl procedure on (b)(6) 2024.Additional information received on 8/26/2024: upon removal of the screw, it was deformed; however, it did not break in the patient.The entire screw was successfully removed.The case was completed using an ar-4030c-09 biocomposite fastthread interference screw.The case was delayed ten minutes without additional anesthesia.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: BIO-INTERFERENCE SCREW
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20087194
• Report Number: 1220246-2024-07291
• Device Sequence Number: 7664202
• Product Code: MAI
• UDI-Device Identifier: 00888867015265
• UDI-Public: 00888867015265
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BIO-INTERFERENCE SCREW
• Device Catalogue Number: AR-1380B
• Device Lot Number: 15033171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown